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Mallinckrodt (MNK) to complete Single Arm Phase 3 Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration in patients with chronic pain

Source Link:
https://clinicaltrials.gov/ct2/show/NCT01709747?term=Mallinckrodt&recr=Open&no_unk=Y&rank=7&submit_fld_opt=

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Additional Information

Additional Relevant Details This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study.
https://clinicaltria...
Additional Relevant Details New Estimated Study completion Date: Dec 2017. Study was originally expected to complete Q2 but was pushed out. 
https://clinicaltria...
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Catalyst Date
Occurred on:
Apr 17, 2018
Occurred Source:
https://clinicaltrials.gov/ct2/show/NCT01709747
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Related Keywords Phase 3 Study, Hydromorphone, Hydromorphone Hcl, Chronic Pain, Intrathecal Administration, Single Arm Study
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